Coverage Policy Manual
Policy #: 1997054
Category: Radiology
Initiated: July 1993
Last Review: April 2018
  Bone Mineral Density Study

Description:
Osteoporosis may be defined as low bone mass which often leads to an increased risk of fragility fractures.  Osteoporosis is a common disease in the elderly due to age-related bone loss in both sexes and menopause-related bone loss in women.  Patients of any age  receiving glucocorticoid therapy are also at risk for bone loss.  Other risk factors for bone loss include history of a bone fracture as an adult, history of adult bone fracture in a first-degree relative, current cigarette smoking, primary hyperparathyroidism, vertebral osteopenia on radiologic exams.
 
The measure of bone mineral density (BMD)  has been suggested as a way of predicting the risk of future fractures.   BMD is used to determine the need for pharmacologic therapy that include hormone replacement therapy, bisphosphonates, selective estrogen receptor modulators, and calcitonin.  
 
BMD is typically expressed in terms of the number of standard deviations (SD) the BMD falls below the mean for young healthy adults, measured as the T score.  National Osteoporosis Foundation guidelines recommend pharmacologic therapy for persons with BMD T scores below -2 or below -1.5 if other risk factors are present.
 
BMD can be measured with several different methods in a variety of sites.  Central sites include the hip and spine, sites most predictive of fragility fractures and where fractures are the most clinically relevant.   Peripheral testing sites include the heel, wrist and finger.  These sites are often tested in screening studies.  
 
BMD testing modalities include:
    • Dual X-ray Absorptiometry (DXA) (CPT 77080 and 77081).  DXA is probably the most commonly used technique to measure BMD.  It is able to measure BMD at both the hip and the spine and involves low radiation exposure.  It can also be used at peripheral sites.  Most of the published studies of pharmacologic therapy for osteoporosis have all used DXA to follow patients.  The correlation coefficient for DXA and ultrasound is only modest and the two types of testing are not considered equivalent;
    • Quantitative Computed Tomography (QCT) (CPT 77078).  QCT is used for central measurements only.  It is usually less available and is associated with relatively high radiation exposure and relatively high cost;
    • Ultrasound Densitometry (CPT 76977).  This is the newest technique for measuring BMD at peripheral sites, usually the heel, but may use the tibia and fingers.  This testing involves no radiation exposure and is readily available in a number of settings including some outside of physician's offices.  Ultrasound testing cannot be used to diagnose osteoporosis.  The clinical utility of this method has not been documented in medical literature;
    • Single and dual photon absorptiometry (CPT 78350, 78351).  These methods are rarely used and dual photon absorptiometry is considered obsolete.
 
When BMD is done for USPSTF recommended screening procedures for osteoporosis, service should be billed with modifier -33. USPSTF recommended screening for osteoporosis includes screening in women aged 65 years or older and in younger women whose fracture risk is equal to or greater than that of a 65-year old white woman who has no additional risk factors.
 

Policy/
Coverage:
Effective April 2017
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage
Criteria
 
Bone mineral density measurement meets primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes in the following circumstances when results are likely to influence a treatment decision:
  • Individuals with vertebral abnormalities or radiographic osteopenia.
  • Individuals with asymptomatic primary hyperparathyroidism to diagnose low bone mass in order to identify those at risk of severe skeletal disease who may be candidates for surgical intervention.
  • Individuals with history of low-impact fracture  
  • Baseline study for individuals receiving long-term glucocorticoids (for more than 3 months at a dose equivalent to or greater than 7.5 mg prednisone daily).
  • Postmenopausal women < 65 years of age who have one of the following risk factors:
      • Menopause, natural or surgical, before age 40
      • History of non-traumatic fracture after age 45 in a first-degree relative
      • Current smoker (one pack or more per day)
      • On no hormone replacement therapy OR on hormone replacement therapy greater than 10-15 years
  • Women age > 65 years of age, regardless of concurrent risk factors.
  • Women < 65 years of age whose fracture risk is at least equal to that of an average risk 65 year old woman according to the FRAX (Fracture Risk Assessment) tool. (Effective, February 2011)
  • Males with one of the following:
      • Age 70 or older
      • Gonadal insufficiency (primary and secondary) (includes androgen suppression)
 
Based on expert opinion, repeat bone mineral density measurement to evaluate response to pharmacologic treatment when this information will affect patient care, meets primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes in the following circumstances:
  • For patients who are on pharmacological therapy for the treatment of osteoporosis if the result of the testing is to be used to alter therapy.
  • DEXA may be done once every eighteen months of therapy with Calcitonin or Bisphosphates to determine the effectiveness of the therapy. If the therapy is judged to be ineffective, and the physician changes to an alternate drug, re-testing within one year to test the effectiveness of the second drug is allowed.
  • In patients receiving long-term therapy with glucocorticoids.
      • Additional scans will be covered no more frequently than yearly and only if medically necessary;
  • In patients with primary asymptomatic hyperparathyroidism.
      • Repeat scans will be allowed annually if the scan result is to be used in the determination for need for surgical intervention.
 
Repeat bone mineral density measurement for patients who previously tested normal and do not require pharmacologic treatment meets primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes at an interval not more frequent than every 3 years to 5 years depending on the risk factors.
 
When axial sites are unavailable or in cases of hyperparathyroidism BMD measurement using ultrasound densitometry, quantitative computed tomography, or dual x-ray absorptiometry may be medically necessary.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary
Coverage Criteria
 
Screening studies are a contract exclusion and are not covered unless the contract has Wellness benefits.
 
The efficacy of using bone density studies to determine 'rapid bone loss' is undetermined and does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes. For members with contracts without primary coverage criteria, bone density studies to determine 'rapid bone loss' are considered investigational. Investigational services are an exclusion in the member benefit contract.
 
Peripheral bone mineral density testing using ultrasound technique is not covered for members based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness. Ultrasound studies of peripheral bone (calcaneus or wrist) do not correlate well with bone mineral density determined at the hip or spine. For members with contracts without primary coverage criteria), peripheral bone mineral density testing using ultrasound technique is considered investigational. Investigational services are an exclusion in the member benefit contract.
 
Single and Dual photon absorptiometry do not meet member benefit certificate primary coverage criteria of effectiveness in improving health outcomes. These technologies have been superseded by more effective technology. For members with contracts without primary coverage criteria, single and Dual photon absorptiometry are considered not medically necessary because these technologies have been superseded by more effective technology.
 
BMD measurement using ultrasound densitometry, quantitative computed tomography, or dual x-ray absorptiometry of peripheral sites does meet member benefit certificate primary coverage criteria of effectiveness in improving health outcomes.
 
For members with contracts without primary coverage criteria, BMD measurement using ultrasound densitometry, quantitative computed tomography, or dual x-ray absorptiometry of peripheral sites are considered investigational. Investigational services are an exclusion in the member benefit contract.
 
Effective Prior to March 2017
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Bone mineral density measurement meets primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes in the following circumstances when results are likely to influence a treatment decision:
    • Individuals with vertebral abnormalities or radiographic osteopenia.
    • Individuals with asymptomatic primary hyperparathyroidism to diagnose low bone mass in order to identify those at risk of severe skeletal disease who may be candidates for surgical intervention.
    • Individuals with history of low-impact fracture
    • Baseline study for individuals receiving long-term glucocorticoids (for more than 3 months at a dose equivalent to or greater than 7.5 mg prednisone daily).
    • Postmenopausal women < 65 years of age who have one of the following risk factors:
        • Menopause, natural or surgical, before age 40
        • History of nontraumatic fracture after age 45 in a first-degree relative
        • Current smoker (one pack or more per day)
        • On no hormone replacement therapy OR on hormone replacement therapy greater than 10-15 years
    • Women age > 65 years of age, regardless of concurrent risk factors.
    • Women < 65 years of age whose fracture risk is at least equal to that of an average risk 65 year old woman according to the FRAX (Fracture Risk Assessment) tool. (Effective, February 2011)
    • Males with one of the following:
        • Age 70 or older
        • Gonadal insufficiency (primary and secondary) (includes androgen suppression)
  
Based on expert opinion, repeat bone mineral density measurement to evaluate response to pharmacologic treatment when this information will affect patient care, meets primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes in the following circumstances:
    • For patients who are on pharmacological therapy for the treatment of osteoporosis if the result of the testing is to be used to alter therapy.
        • DEXA may be done once every eighteen months of therapy with Calcitonin or Bisphosphates to determine the effectiveness of the therapy.  If the therapy is judged to be ineffective, and the physician changes to an alternate drug, re-testing within one year to test the effectiveness of the second drug is allowed.  
    • In patients receiving long-term therapy with glucocorticoids.
        •  Additional scans will  be covered no more frequently than yearly and only if medically necessary;
    • In patients with primary asymptomatic hyperparathyroidism.
        • Repeat scans will be allowed annually if the scan result is to be used in the determination for need for surgical intervention.
 
Repeat bone mineral density measurement for patients who previously tested normal and do not require pharmacologic  treatment  meets primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes at an interval not more frequent than every 3 years to 5 years depending on the risk factors.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Screening studies are a contract exclusion and are not covered unless the contract has Wellness benefits.
 
The efficacy of using bone density studies to determine 'rapid bone loss' is undetermined and does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes. For members with contracts without primary coverage criteria, bone density studies to determine 'rapid bone loss' are considered investigational.  Investigational services are an exclusion in the member benefit contract.
  
Peripheral bone mineral density testing using ultrasound technique is not covered for members covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.  Ultrasound studies of peripheral bone (calcaneus or wrist) do not correlate well with bone mineral  density determined at the hip or spine. For members with contracts without primary coverage criteria), peripheral bone mineral density testing using ultrasound technique is considered investigational.  Investigational services are an exclusion in the member benefit contract.
  
Single and Dual photon absorptiometry do not meet member benefit certificate primary coverage criteria of effectiveness in improving health outcomes.  These technologies have been superseded by more effective technology.  For members with contracts without primary coverage criteria, single and Dual photon absorptiometry are considered not medically necessary because these technologies have been superseded by more effective technology.
 
Effective March 2005 - November 2010
Bone mineral density measurement meets primary coverage criteria for effectiveness and is covered in the following circumstances when results are likely to influence a treatment decision:
    • Individuals with vertebral abnormalities or radiographic osteopenic individuals with asymptomatic primary hyperparathyroidism to diagnose low bone mass in order to identify those at risk of severe skeletal disease who may be candidates for surgical intervention.
    • Individuals with history of low-impact fracture
    • Baseline study for individuals receiving long-term glucocorticoids (for more than 3 months at a dose equivalent to or greater than 7.5 mg prednisone daily)
    • Postmenopausal women < 65 years of age who have an additional risk factor:
      • Menopause, natural or surgical, before age 40
      • History of nontraumatic fracture after age 45 in a first-degree relative
      • Current smoker (one pack or more per day)
      • On no hormone replacement therapy OR on hormone replacement therapy greater than 10-15 years
    • Women age > 65 years of age, regardless of concurrent risk factors
    • Males with one of the following:
      • Age 70 or older
      • Gonadal insufficiency (primary and secondary) (includes androgen suppression)
 
Repeat medically necessary bone mineral density measurement will be allowed:
    • For patients who are on therapy with Calcitonin or Bisphosphates, and the physician is assessing effectiveness of therapy (if the result of the testing is to be used to alter therapy), DEXA may be done once every eighteen months of therapy with Calcitonin or Bisphosphates to determine the effectiveness of the therapy.  If the therapy is judged to be ineffective, and the physician changes to an alternate drug, re-testing within one year to test the effectiveness of the second drug is allowed.  The ICD-9-CM code that is used should be one of the categories that we have listed; The type of drug listed would be Calcitonin, Bisphosphates, or Estrogen;
    • In patients receiving long-term therapy with glucocorticoids additional scans will be covered no more frequently than yearly and only if medically necessary;
    • In patients with primary asymptomatic hyperparathyroidism, repeat scans will be allowed annually  if the scan result is to be used in the determination for need for surgical intervention.
 
The efficacy of using bone density studies to monitor patients to determine when there has been response to therapy has yet to be determined.  The efficacy of using bone density studies to determine 'rapid bone loss' is also undetermined.  In these circumstances, bone density studies are not covered based on member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, bone density studies to monitor patients to determine when there has been response to therapy or to determine 'rapid bone loss' are considered investigational.  Investigational services are an exclusion in the member benefit contract.
 
Screening studies are a contract exclusion and are not covered unless the contract has Wellness benefits.
 
Peripheral bone mineral density testing using ultrasound technique is not covered for members covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.  Ultrasound studies of peripheral bone (calcaneus or wrist) do not correlate well with bone mineral density determined at the hip or spine.
 
For members with contracts without primary coverage criteria), peripheral bone mineral density testing using ultrasound technique is considered investigational.  Investigational services are an exclusion in the member benefit contract.
 
Single and Dual photon absorptiometry are not covered based on benefit certificate primary coverage criteria.  These technologies have been superseded by more effective technology.
 
For members with contracts without primary coverage criteria, single and Dual photon absorptiometry are considered not medically necessary because these technologies have been superseded by more effective technology.
 
Effective September 2002 – February 2005
Dual Energy X-ray Absorptiometry is covered for patients who fall into the following clinical categories:  (1) Women who are deficient in estrogen; used as a means of identifying those with low bone mass and to help physicians and patients make decisions about hormone replacement therapy.  (It should be understood that not all menopausal women are included in this recommendation).  Many women choose not to take estrogen, and others receive hormonal replacement therapy for reasons other than the prevention of osteoporosis.  This should, therefore, not be construed as a recommendation for the general screening of all menopausal women but as an approach to help women with specific problems.  Screening procedures are not covered.  For patients in this category, testing will be allowed no more frequently than every three to five years, if medically necessary; (2) In patients with vertebral abnormalities or roentgenographic osteopenia; (3) A baseline study for patients receiving long-term therapy with glucocorticoids, (4) In patients with primary asymptomatic hyperparathyroidism to diagnose low bone mass in order to identify those at risk of severe skeletal disease who may be candidates for surgical intervention.
 
The efficacy of using bone density studies to monitor patients to determine when there has been response to therapy has yet to be determined.  The efficacy of using bone density studies to determine 'rapid bone loss' is also undetermined.   Medically necessary Dual Energy X-ray Absorptiometry will be allowed:   (1) For patients who are on therapy with Calcitonin or Bisphosphates, and the physician is assessing effectiveness of therapy (if the result of the testing is to be used to alter therapy), DEXA may be done once every eighteen months of therapy with Calcitonin or Bisphosphates to determine the effectiveness of the therapy.  If the therapy is judged to be ineffective, and the physician changes to an alternate drug, re-testing within one year to test the effectiveness of the second drug is allowed.  The ICD-9-CM code that is used should be one of the categories that we have listed; The type of drug listed would be Calcitonin, Bisphosphates, or Estrogen; (2) In patients receiving long-term therapy with glucocorticoids additional scans will be covered no more frequently than yearly and only if medically necessary; (3) In patients with primary asymptomatic hyperparathyroidism, repeat scans will be allowed annually  if the scan result is to be used in the determination for need for surgical intervention.
 
Ultrasound densitometry measurement of bone mineral density is considered a screening study and is not covered.
 
Single and Dual photon absorptiometry are considered not medically necessary because these technologies have been superseded by more effective technology and are not covered.
 
Effective July 1983 – August 2002
An ad hoc subcommittee of the Scientific Advisory Board of the National Osteoporosis Foundation prepared a document for the Health Care Financing Administration identifying four indications for measurement of bone mass that were thought to be justified by published evidence.  Dual Energy X-ray Absorptiometry is covered for patients who fall into the following  clinical categories:  (1) Women who are deficient in estrogen; used as a means of identifying those with low bone mass and to help physicians and patients make decisions about hormone replacement therapy.  (It should be understood that not all menopausal women are included in this recommendation).  Many women choose not to take estrogen, and others receive hormonal replacement therapy for reasons other than the prevention of osteoporosis.  This should, therefore, not be construed as a recommendation for the general screening of all menopausal women but as an approach to help women with specific problems.  Screening procedures are not covered.  For patients in this category, testing will be allowed no more frequently than every three to five years, if medically necessary; (2) In patients with vertebral abnormalities or roentgenographic osteopenia; (3) In patients receiving long-term therapy with glucocorticoids, the procedure may be repeated within six months of starting glucocorticoids  if the result is used to reduce therapy.  If a reduction in the dose of glucocorticoid is not possible despite the result of the DEXA scan, the procedure will not be covered.  
 
Subsequent to the six-month scan, additional scans will be covered no more frequently than yearly and only if medically necessary to evaluate for rapid development of osteoporosis; (4) In patients with primary asymptomatic hyperparathyroidism to diagnose low bone mass in order to identify those at risk of severe skeletal disease who may be candidates for surgical intervention.
 
The efficacy of using bone density studies to monitor patients to determine when there has been response to therapy has yet to be determined.  The efficacy of using bone density studies to determine 'rapid bone loss' is also undetermined.   Medically necessary Dual Energy X-ray Absorptiometry will be allowed:  (1) Once every two years for patients described under category one above; (2) For patients who are on therapy with Calcitonin or Bisphosphates, and the physician is assessing effectiveness of therapy (if the result of the testing is to be used to alter therapy), DEXA may be done once every eighteen months of therapy with Calcitonin or Bisphosphates to determine the effectiveness of the therapy.  If the therapy is judged to be ineffective, and the physician changes to an alternate drug, re-testing within one year to test the effectiveness of the second drug is allowed.  The ICD-9-CM code that is used should be one of the categories that we have listed; The type of drug listed would be Calcitonin, Bisphosphates, or Estrogen; (3) In patients receiving long-term therapy with glucocorticoids, the procedure may be repeated within six months of starting glucocorticoids if the result is used to reduce therapy.  If a reduction in dose of glucocorticoid is not possible despite the result of the DEXA scan, the procedure will not be covered.  Subsequent to the six-month scan, additional scans will be covered no more frequently than yearly and only if medically necessary; (4) In patients with primary asymptomatic hyperparathyroidism, repeat scans will be allowed annually  if the scan result is to be used in the determination for need for surgical intervention.
 
Single and Dual photon absorptiometry are considered not medically necessary because these technologies have been superseded by more effective technology and are not covered.
 
Ultrasound densitometry measurement of bone mineral density is considered a screening study and is not covered. (Effective July 2002)
  

Rationale:
The National Osteoporosis Foundation (NOF) guidelines exist in 2 formats; a formal background report and a summary version presented as a “Physician’s Guide.”  Although bone mineral density (BMD) measurements at the clinically relevant central sites (i.e., hip and spine) are most predictive of future fracture risk, the Physician’s Guidelines do not recommend one particular type or site of BMD testing technology, although the background report states that hip measurements are preferred. A literature search in 1999 specifically addressed the use of ultrasound densitometry of the heel, not only to assess fracture risk, but to predict response to drug therapy.  Although these outcomes may seem the same, there is a subtle but important distinction. While both DXA and ultrasound densitometry were equivalent in predicting fracture risk, the correlation coefficient was only modest, suggesting that the 2 techniques identified different populations of at-risk patients. Recent randomized trials of various drug therapies, such as bisphosphonates, selective estrogen receptor modulators, and calcitonin, have all used DXA to measure therapy-induced changes in bone mineral density. Thus, it is not clear whether the results of these trials can be extrapolated to the potentially different population of at-risk patients identified by ultrasound densitometry.  A literature search in 2002 focused on the use of ultrasound densitometry performed at peripheral sites other than the heel, i.e., at the phalanges or tibia.  The conclusion was the same limitations regarding the evidence of ultrasonography of the heel applied to other peripheral sites. Specifically, ultrasound of any site is a poor predictor of DXA and thus cannot be used to direct patients’ treatment.
 
Another issue related to BMD testing is the need for serial monitoring to assess treatment response. The NOF guidelines did not explicitly address serial monitoring, although the cost effectiveness analysis in the background report assumed that the patient would undergo a single assessment of BMD. (The NOF screening guidelines were based in part on this cost-effectiveness analysis.)
    • There is no direct evidence regarding the utility of BMD monitoring in patients undergoing treatment for osteoporosis.
    • Lacking this direct evidence, the chain of logic supporting BMD monitoring is very weak and does not indicate a benefit. Given the precision of BMD measurement using DXA, the expected changes in BMD and variability of those changes as a result of treatment, it is only possible under situations in which there is a great loss of bone where it is possible to identify a patient who is not responding to treatment. Even then, the patients may actually be responding by losing less BMD than they would have without treatment.
    • There is no direct evidence that alternative treatments or adjustments in management will be effective in those judged to be nonresponder to their initial treatment.
 
For unknown reasons, treatment-related changes in BMD are not observed at peripheral sites and thus ultrasound densitometry of the heel cannot be used for serial monitoring. This suggests that if serial monitoring is considered, a central DXA BMD measurement should be the initial BMD test performed in patients at high risk for osteoporosis. A central DXA measurement will simultaneously establish the diagnosis of osteoporosis and provide a baseline.
 
2010 Update
A search of the MEDLINE database was conducted through September 2010.
 
Longitudinal changes in BMD, as a function of age and antiresorptive agents, were reported by the Canadian Multicentre Osteoporosis Study Research Group (Berger, 2008).  Of a random selection of 9,423 men and women from 9 major Canadian cities, 4,433 women and 1,935 men (70%) were included for analysis. The subjects were 25 years of age or older with BMD measurements repeated 3 or 5 years apart; they tended to have better health than the 30% who did not have longitudinal data and who were excluded from analysis. Results showed that annual rates of bone loss, measured at the hip or femoral neck, increased between 25 to 85 years of age in women who were not on antiresorptive therapy, with accelerated periods of bone loss around menopausal transition (40–54 years of age) and after 70 years of age. Antiresorptive therapy, which consisted primarily of hormone replacement when the study began in 1995, was associated with attenuated bone loss across all age ranges. In women 50–79 years of age, the average loss in BMD over a 5-year period was 3.2% in nonusers of antiresorptive therapy and 0.2% in women who used antiresorptive therapy. The pattern in men was generally similar to that of women with two exceptions, BMD loss began earlier in men, and the rate of change remained relatively constant between 40 and 70 years of age. Notably, BMD at the lumbar spine did not parallel measurements at the hip and femoral neck, suggesting that vertebral bone density assessment may be obscured by degenerative changes in the spine or other artifact. The report concluded that “although current guidelines recommend that measurements of bone density be repeated once every 2–3 years, our data suggest that, at this rate of testing, the average person would exhibit change well below the margin of error, especially since only 25% of women experienced a loss of bone density that exceeded 5% over 5 years.” Poor concordance between different densitometers (e.g., Prodigy and DPX) has also been reported for BMD change measured over 2 years (Frost, 2007).
 
Frost and colleagues developed a prognostic model to determine the optimal screening interval for an individual without osteoporosis (defined as T-score more than -2.5) (Frost, 2009).  They used prospective population-based data collected from 1,008 women and 750 men who were non-osteoporotic at baseline; participants received BMD screening every 2 years and received a median follow-up of 7.1 years. The prognostic model included the variables of age and initial BMD score; results were presented in complex tables stratified by these two variables. In the table of estimated time to reach 20% risk of sustaining a fracture or osteoporosis, most of the time estimates were 3 years or longer. The shortest time to reach a 20% risk was estimated at 2.4 years; this was for women 80 years and older with a baseline T-score of -2.2. For a typical screening candidate, a 65-year-old woman with a baseline T-score of –1.0, the estimated time to reach a 10% risk of fracture was 3.8 years and to reach a 20% risk of fracture was 6.5 years. Overall, the study suggests that the 3- to 5-year time interval included in the policy for repeat measurement of BMD in people who tested normal is reasonable, but that an individualized model could result in longer or shorter recommended re-testing intervals.
 
Bell and colleagues conducted a secondary analysis of data from the Fracture Intervention Trial (FIT), which randomized 6,459 post-menopausal women with low BMD to receive treatment with bisphosphonates or placebo; women underwent annual bone density scans (Bell, 2009).  In their analysis, the investigators estimated between-person (treatment-related) variation and within-person (measurement-related) variation in hip and spine BMD over time to assess the value of repeat bone mineral density scans for monitoring response to treatment. After 3 years, the mean cumulative increase in hip bone mineral density was 0.30 g/cm2 in the alendronate group compared to a mean decrease of 0.012 g/cm2 in the placebo group. Moreover, 97.5% of patients treated with alendronate had increases in hip bone mineral density of at least 0.019 g/cm2, suggesting a clinically significant response. However, the study also found large within-person variability in year-to-year bone density measurements. The average within-person variation in BMD measurement was 0.013 g/cm2, which was substantially higher than the average annual increase in BMD in the alendronate group, 0.085 g/cm2. This finding suggests that the precision of BMD measurement is not reliable from year to year, and thus annual re-testing is not useful. Additional studies are needed to determine the optimal time interval for re-screening after starting bisphosphonate treatment.
 
Recently, there has been interest in gastric bypass surgery as a potential risk factor for osteoporosis. Several case series have found a significant decrease in BMD at one or more sites following gastric bypass surgery. For example, Carrasco and colleagues reported on a series of 42 women, mean age 38 years, who underwent gastric bypass surgery (Carrasco, 2009).  A year after surgery there was a significant reduction of 3% in total BMD, reduction of 10.5% in hip BMD and reduction of 7.4% in spine BMD. Another case series by Fleischer and colleagues included 23 individuals, aged 20–64 years, who had gastric bypass surgery (Fleischer, 2008).   After 1 year of follow-up, there was a significant decrease in hip BMD, a mean loss of 9.2% at the femoral neck and 8.0% of the total hip. There was not a significant difference in lumbar spine BMD. Decline in BMD was strongly associated with the extent of weight loss and the authors speculated that this change might, in part, be due to unloading of the skeleton. Moreover, the authors comment that the study had a small sample size and larger longer-term studies are needed to answer the question of how bone density loss accompanying weight loss affects bone quality and fracture risk. The 1 comparative study that was identified had a different finding as regards hip BMD. This was a retrospective cohort study by Valderas and colleagues. It included 26 post-menopausal women (mean age 58 years) who underwent Roux-en-Y gastric bypass and 26 women non-operated women matched for age and body mass index (Valeras, 2009).   After a mean of 3.1 years after surgery, the mean decrease in femoral neck BMD s 0.892 g/cm2 in the gastric bypass group and 0.934 cm2 in the comparison group; this difference was not statistically significant. Differences in lumbar spine BMD also did not differ significantly. Two clinical guidelines, the National Osteoporosis Foundation (NOF) and the American Association of Clinical Endocrinologists (AACE) list gastric surgery as one of many factors linked to an increased risk of osteoporosis or fracture.
 
Technology Assessments, Guidelines and Position Statements
 
The NOF updated its practice guidelines in 2008.  Current NOF guidelines recommend that all postmenopausal women and older men should be evaluated clinically for osteoporosis risk to determine the need for BMD testing. In general, the more risk factors that are present, the greater the risk of fracture. BMD assessment is indicated in:
 
    • Women age 65 and older and men age 70 and older, regardless of other risk factors;
    • Younger postmenopausal women and men aged 50–70 about whom you have concern based on their clinical risk factor profile;
    • Women in the menopausal transition if there is a specific risk factor associated with increased fracture risk such as low body weight, prior low-trauma fracture, or high-risk medication;
    • Adults who have a fracture after age 50;
    • Adults with a condition (e.g., rheumatoid arthritis) or taking a medication (e.g., glucocorticoids, =5 mg/day for =3 months) associated with low bone mass or bone loss;
    • Anyone being considered for pharmacologic therapy for osteoporosis;
    • Anyone not receiving therapy in whom evidence of bone loss would lead to treatment;
    • Postmenopausal women discontinuing estrogen should be considered for bone density testing.
 
The NOF guidelines suggest that BMD measurement is not indicated unless the results will influence the patient’s treatment decision, and that serial monitoring of BMD is appropriate for monitoring bone loss in patients on pharmacotherapy (commonly performed at 2-year intervals). These guidelines are based on economic analysis that takes into consideration the cost effectiveness of treatments and competition for resources in the United States. NOF analysis concluded that it is cost effective to treat individuals with a prior fracture and those with BMD T scores below -2.5 in the absence of other risk factors, and in individuals with BMD T scores between -1.0 and -2.5 (osteopenia), if other risk factors are present (this is a change from prior recommendations).
 
The U.S. Surgeon General published a report on bone health and osteoporosis in 2004.  DXA measurements were considered precise enough to be used for monitoring patients over time, provided the interval between measurements is tailored to the specific patient’s situation. Several points were made regarding the most appropriate approaches for BMD monitoring.
 
    • For individuals who are not currently receiving treatment, the timing of a repeat test should be based on the current BMD and the expected rate of bone loss (e.g., faster during early menopause). For older individuals with above-average T-scores, repeat testing may not be necessary at all. For younger individuals who were initially screened due to risk factors but who have normal BMD values, repeat testing every 5–10 years may be helpful.
    • For monitoring patients on treatment, testing annually is inappropriate, unless receiving high-dose long-term glucocorticoid therapy. There is insufficient evidence to determine if testing every 2 years is useful.
    • When repeating BMD measurements, it is important to avoid over-interpretation of small changes as these can be due to differences in equipment or changes in positioning. One important point of concern about the interpretation of results is the variability that exists across BMD machines. Despite the limitations, bone mineral density remains the single best predictor of fracture risk available today.
 
Guidelines from the U.S. Preventative Services Task Force (USPSTF) in 2002 recommend that women aged 65 and older should be screened routinely for osteoporosis with bone density measurements.  The USPSTF recommends that routine screening begin at age 60 for women at increased risk for osteoporotic fractures and “makes no recommendation for or against routine osteoporosis screening in postmenopausal women who are younger than 60 or in women aged 60–64 who are not at increased risk for osteoporotic fractures.” The available evidence indicated that screening women at lower risk can identify women who may be eligible for treatment, but it would prevent a small number of fractures. Regarding repeat testing, the report states that no studies have evaluated the optimal intervals for repeated screening. “Because of limitations in the precision of testing, a minimum of 2 years may be needed to reliably measure a change in bone mineral density; however, longer intervals may be adequate for repeated screening to identify new cases of osteoporosis. Yield of repeated screening will be higher in older women, those with lower BMD at baseline, and those with other risk factors for fracture. No data were available to determine the appropriate age to stop screening.  An updated literature review for the USPSTF recommendation on osteoporosis screening (Nelson, 2010) was published in July 2010.  The findings from this review, do not impact the coverage statement. The USPSTF posted a draft of their updated guidelines for public comment but have not finalized the updated guidelines at the time of this policy update.
 
2008 guidelines from the American College of Physicians (ACP) recommend that clinicians periodically perform individualized assessment of risk factors for osteoporosis in men older than 50 years (Grade: strong recommendation; moderate-quality evidence).  Factors that increase the risk for osteoporosis in men include age (>70 years), low body mass index (BMI), weight loss, physical inactivity, corticosteroid use, androgen deprivation therapy, and previous fragility fracture. The ACP recommends that clinicians obtain DXA for men who are at increased risk for osteoporosis and are candidates for drug therapy (Grade: strong recommendation; moderate-quality evidence). The guidelines indicate that bone density measurement with DXA is the accepted reference standard for diagnosing osteoporosis in men; because treatment trials have not measured the effectiveness of therapy for osteoporosis diagnosed by ultrasound densitometry rather than DXA, the role of ultrasound in diagnosis remains uncertain. This evidence review found no studies that evaluated the optimal intervals for repeated screening by using BMD measurement with DXA in men.
 
Practice guidelines from the American College of Radiology (ACR), amended in 2006 and 2007, recommend that BMD measurement is indicated whenever a clinical decision to intervene will be directly influenced by the result of the test (Bradford, 2007).  The ACR states that BMD measurement is used to identify patients with low bone density and increased fracture risk or patients being monitored to assess the response to or efficacy of an FDA-approved osteoporosis drug therapy, with DXA being the gold standard and the only BMD technology for which WHO criteria for diagnosis of osteoporosis, originally for postmenopausal Caucasian women over age 65, can be used. Follow-up for treatment can be performed using DXA and QCT only and “should be performed at appropriate intervals as indicated.” All other measurements are peripheral and for identifying individuals at risk for fracture and low BMD (pDXA, pQCT, SXA, QUS). Hyperparathyroidism is an exception to routine BMD testing in which the forearm is essential for diagnosis. Another exception is pediatric patients in whom DXA can measure spine, but total body calcium is preferred because it helps reduce the issue of following patients with growing bones.
 
Guidelines from the American College of Obstetricians and Gynecologists (ACOG) from 2004 indicate that testing of BMD should be performed on the basis of an individual woman’s risk profile and is not indicated unless the results will influence a treatment or management decision.  The following guidelines were recommended:
 
    • BMD testing should be performed on all postmenopausal women with fractures to confirm the diagnosis of osteoporosis and determine disease severity;
    • BMD testing should be recommended to all postmenopausal women aged 65 years or older;
    • BMD testing may be recommended to postmenopausal women younger than 65 years who have 1 or more risk factors for osteoporosis. (see below “Risk Factors for Osteoporotic Fracture in Postmenopausal Women”*);
    • BMD testing may be useful for premenopausal and postmenopausal women with certain diseases or medical conditions and those who take certain drugs associated with an increased risk of osteoporosis.
 
ACOG recommends that in the absence of new risk factors, subsequent screening should not be performed more frequently than every 2 years. The usefulness of repeated screening will be greater in older women, those with lower baseline BMD, and those with numerous risk factors. For older women who have experienced an osteoporotic vertebral fracture, treatment may be given without BMD measurement, although baseline BMD testing may be useful to follow the effects of therapy. A non-vertebral fracture (e.g., hip or wrist) is, by itself, not an indication for treatment in the absence of low BMD. Testing of BMD in early postmenopausal women may be of value in helping women make a decision about preventive therapy; however, it cannot be justified on the basis of fracture reduction in the short term.
 
Guidelines from the American Association of Clinical Endocrinologists (AACE), published in 2003, indicate that in women who are at risk for postmenopausal osteoporosis, BMD measurement can accomplish the following:
 
    • Establish the diagnosis of postmenopausal osteoporosis;
    • Determine fracture risk;
    • Identify candidates for intervention;
    • Assess changes in bone mass over time in treated and untreated patients;
    • Enhance acceptance of and adherence to treatment.
 
Specifically regarding serial BMD measurements, the AACE guidelines state that they are “useful for monitoring changes in bone mass. Each technique for evaluation of bone density has an inherent variability (that is, precision error) that must be considered when the clinical significance of BMD changes is assessed…..Until specific data about the most efficient use of BMD for monitoring become available, the following general guidelines for performing follow-up BMD measurements may be used:
 
    • For patients with “normal” baseline BMD (T-score more than -1.0), consider a follow-up measurement every 3 to 5 years. Patients whose bone density is well above the minimal acceptable level may not need further BMD testing.
    • For patients in an osteoporosis prevention program, perform a follow-up measurement every 1 to 2 years until bone mass stability is documented. After BMD has stabilized, perform follow-up measurements every 2 to 3 years.
    • For patients on a therapeutic program, perform a follow-up measurement yearly for 2 years. If bone mass has stabilized after 2 years, perform a follow-up measurement every 2 years. Otherwise, continue with annual follow-up measurements until stability of bone mass is achieved.”
 
The American College of Rheumatology Ad Hoc Committee on Glucocorticoid-Induced Osteoporosis (2001) recommends obtaining a baseline measurement of BMD at the lumbar spine and/or hip when initiating long-term (i.e., >6 months) glucocorticoid therapy.  Longitudinal measurements may be repeated as often as every 6 months for monitoring glucocorticoid-treated patients to detect bone loss. In patients who are receiving therapy to prevent bone loss; annual follow-up measurements are probably sufficient.
 
The Institute for Clinical Systems Improvement (ICSI) recommends:
 
The bone density testing in individuals as follows:
  
    • Prior fracture with minor trauma (fall from a standing height or less);
    • Those who have been or are anticipated to be receiving glucocorticoid therapy for 3 more months at a dose equivalent to or greater than 5 mg prednisone per day;
    • Radiographic osteopenia or vertebral deformity consistent with fracture;
    • All women 65 year of age or older;
    • Postmenopausal women younger than age 65 with one of the following additional risk factors:
    • Body weight less than 127 lbs or a BMI of 20 or less;
    • History of nontraumatic fracture after age 45 in a first-degree relative;
    • Current smoker;
    • Not using hormone replacement therapy;
    • Surgical menopause, or natural menopause before age 40;
    • Chronic diseases known to be associated with bone loss;
    • Premenopausal women with amenorrhea greater than 1 year;
    • Men with hypogonadism more than 5 years;
    • Prolonged severe loss of mobility (unable to ambulate outside of one’s dwelling without a wheelchair for greater than 1 year);
    • Solid organ or allogeneic bone marrow transplant recipient;
    • Medications for malignancy are likely to cause bone loss.
 
The 2007 International Society for Clinical Densitometry (ISCD) guidelines recommend bone density testing in the following patients:  
 
    • Women age 65 and older;
    • Postmenopausal women under age 65 with risk factors for fracture;
    • Women during the menopausal transition with clinical risk factors for fracture, such as low bone weight, prior fracture or high-risk medication use;
    • Men age 70 and older;
    • Men under age 70 with clinical risk factors for fracture;
    • Adults with a fragility fracture;
    • Adults with a disease or condition associated with low bone mass or bone loss;
    • Adults taking medications associated with low bone mass or bone loss;
    • Anyone being considered for pharmacologic therapy;
    • Anyone not receiving therapy in whom evidence of bone loss would lead to treatment.
 
The 2010 position statement of The North American Menopause Society recommends the following:
 
    • Bone density testing in the following patients:
        • All postmenopausal women with medical causes of bone loss
        • All women age 65 years and older
        • Should be considered for postmenopausal women age 50 and older who have one or more of the following risk factors: Previous fracture (other than skull, facial bone, ankle, finger, and toe) after menopause; Thinness (body weight <127 lb or body mass index <21kg/m²;History of hip fracture in a parent; Current smoking; Rheumatoid arthritis; Excessive alcohol intake
    • During pharmacologic treatment, it is appropriate to reevaluate the treatment goals and the choice of medication on an ongoing basis through periodic medical examination and a follow-up BMD testing.  An appropriate interval for repeat BMD testing is after 1 to 2 years of treatment.
    • For untreated postmenopausal women, repeat DXA testing is not useful until 2 to 5 years have passed.
 
2011 Update
In January 2011, the U.S. Preventative Services Task Force (USPSTF) issued updated recommendations on screening for osteoporosis with bone density measurements.  The USPSTF recommends routine osteoporosis screening in women age 65 years or older, and in younger women whose risk of fracture is at least equal to that of a 65-year old average-risk white woman. This represents a change from the previous (2002) version in which there was no specific recommendation regarding screening in women younger than 65 years old. The supporting document notes that there are multiple instruments to predict risk for low BMD, and that the USPSTF used the FRAX tool.  The FRAX tool can be accessed online at: http://www.shef.ac.uk/FRAX/.  The USPSTF recommends using a 9.3% 10-year fracture risk threshold to screen women between the ages of 50 and 64 years. The updated USPSTF recommendations state that the scientific evidence is insufficient to recommend for or against routine osteoporosis screening in men. The Task Force did not recommend specific screening tests, but said that the most commonly used tests are DXA of the hip and lumbar spine and quantitative ultrasound of the calcaneus. The recommendations state the following on screening intervals: “…A lack of evidence exists about the optimal intervals for repeat screening and whether repeated screening is necessary in a woman with normal BMD. Because of limitations in the precision of testing, a minimum of two years may be needed to reliably measure a change in BMD; however, longer intervals may be necessary to improve fracture risk prediction.”
 
2012 Update
A literature search conducted through September 2012 did not identify any new information that would prompt a change in the coverage statement.
 
2013 Update
A search of the MEDLINE database was conducted through September 2013. There was no new information identified that would prompt a change in the coverage statement. The following is a summary of the key identified literature.
 
A 2012 multicenter prospective study by Gourlay and colleagues provided data on the optimal bone density screening interval in a large cohort of women with normal BMD or osteopenia at an initial screen (Gourlay, 2012). The investigators included a total of 4,957 women age 67 years or older who had BMD data at 2 or more examinations or at one examination before a competing risk event (hip or clinical vertebral fracture). More than 99% of the sample reported they were white. The study only included women who were candidates for osteoporosis screening. Other women, such as those with osteoporosis at baseline or with a history of a hip or clinical vertebral fracture were excluded, as they would already be candidates for pharmacological treatment (Hillier, 2007). The primary study outcome was the estimated time interval for 10% of participants to make the transition from normal BMD or osteopenia at baseline to osteoporosis before a hip or clinical vertebral fracture occurred and before starting osteoporosis treatment. For women with normal BMD at baseline, the estimated BMD testing interval was 16.8 years (95% confidence interval [CI]: 11.5 to 24.6). The study found that the estimated BMD testing interval was 17.3 years (95% CI: 13.9 to 21.5) for women with mild osteopenia at baseline, 4.7 years (95% CI: 4.2 to 5.2) with moderate osteopenia, and 1.1 years (95% CI: 1.0 to 1.3) for women with advanced osteopenia. Findings of this study have not been incorporated into national guidelines.
 
In 2012, the American College of Obstetricians and Gynecologists (ACOG) issued updated guidelines on managing osteoporosis in women (ACOG, 2012). The guidelines recommend that BMD screening should begin for all women at age 65 years. In addition, they recommend screening for women younger than 65 years in whom the Fracture Risk Assessment (FRAX) Tool indicates a 10-year risk of osteoporotic fracture of at least 9.3%. Alternatively, they recommend BMD screening women in younger than 65 or with any of the following risk factors (these are similar, but not identical to risk factors in FRAX):
 
  • Personal medical history of a fragility fracture
  • Parental medical history of hip fracture
  • Weight less than 127 lb
  • Medical causes of bone loss (i.e., medications or disease)
  • Current smoker
  • Alcoholism
  • Rheumatoid arthritis
 
For women who begin medication treatment for osteoporosis, a repeat BMD is recommended 1 to 2 years later to assess effectiveness. If BMD is improved or stable, additional BMD testing (in the absence of new risk factors) is not recommended. The guideline notes that it generally takes 18-24 months to document a clinically meaningful change in BMD and thus a 2-year interval after treatment initiation is preferred to 1 year.
 
The guidelines do not specifically discuss repeat BMD screening for women who have a normal finding on the initial test.
 
Routine BMD screening is not recommended for newly menopausal women as a “baseline” screen.
 
 
2014 Update
A literature search conducted through July 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
In 2014, Gadam et al performed a cross-sectional analysis of data to evaluate the incremental predictive ability of BMD when added to the FRAX model. The study included 151 subjects (145 women, 6 men) older than 50 years of age without a prior osteoporosis diagnosis and who were not being treated with U.S. Food and Drug Administration (FDA)-approved medications for treating osteoporosis (Gadam, 2013). Of the 151 individuals, predictions of 10-year fracture risk were identical for 127 patients (84%) when BMD was added to the FRAX model compared with the FRAX model without BMD. Of the subjects who had different risk estimates, the difference in risk prediction resulted in an additional 2 patients meeting the NOF threshold for treatment when BMD was added to the FRAX model. Age was the only risk factor that differed significantly between participants with identical versus different recommendations (p<0.001). Subjects who were younger (mean age, 64 years) were more likely to receive identical predictions than older subjects (mean age, 76 years). The study had a relatively small sample size and lacked longitudinal data on fracture. It provides some initial evidence that BMD may not add substantially to the predictive ability of the FRAX models, but these findings need to be corroborated in prospective studies with larger sample sizes.
 
Other studies suggesting that a longer time interval may be used or that repeat BMD measurements may not be critical include a 2007 study by Hillier et al. The study did not find that follow-up BMD measurements 8 years after a baseline screen provided substantial value in terms of predicting risk of fracture The study included 4124 women age 65 years and older and assessed total hip BMD at initial and follow-up screening examinations. In analyses adjusted for age and weight change, the initial and repeat BMD measurements had similar associations with fracture risk; this included risk of vertebral fractures, nonvertebral fractures, and hip fractures. Stratifying the analysis by initial BMD T scores (ie, normal, osteopenic, osteoporotic) did not alter findings. Moreover, a 2013 study by Berry et al did not find that changes in BMD 4 years after initial measurement added substantially to the prediction of fracture risk in untreated subjects (Berry, 2013). The authors conducted a population-based cohort study including 210 women and 492 men (mean age, 75 years) who had 2 BMD measurements a mean of 3.7 years apart and did not have a hip fracture before the second test. Median follow-up was 9.6 years after the second BMD test. During this time, 76 individuals experienced a hip fracture and 113 had a major osteoporotic fracture (fracture of the hip, spine, forearm or shoulder). In receiver operating curve (ROC) analyses, adding repeat BMD to a model containing baseline BMD did not meaningfully improve the model’s ability to predict hip fracture (area under the curve [AUC], 0.72; 95% CI, 0.66 to 0.79). When percent change in BMD was used, the AUC was 0.71 (95% CI, 0.65 to 0.78) in a model including only baseline BMD and 0.68 (95% CI, 0.62 to 0.75) in a model including percent change in BMD.
 
Practice guidelines from the American College of Radiology (ACR), last amended in 2010, state that BMD measurement is usually appropriate in the following patient populations (ACR, 2014):
  • Postmenopausal females, greater than 50 years of age, females in menopausal transition (late 40s) and males greater than 50 years of age with risk factors.
  • Premenopausal females with risk factors and males 20 to 50 years of age with risk factors.
  • Males and females greater than 50 years of age with advanced degenerative changes of the spine with or without scoliosis.
  • Individuals with suspected fracture, incident or prevalent, of a vertebral body based on clinical history, height loss, or patient treated with corticosteroids.
  • Follow-up in patients demonstrated to have risk for fracture or low density.
  • Follow-up to low BMD in premenopausal females with risk factors and males 20 to 50 years of age with risk factors.
 
2015 Update
A literature search conducted through April 2015 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Serial Measurement of Central BMD to Monitor Discontinuation of Treatment
In 2014, Bauer and colleagues reported fracture risk prediction among women who discontinued alendronate after 4 to 5 years of treatment in the FLEX (Fracture Intervention Trial Long-term Extension) study (Bauer, 2014).  Women aged 61 to 86 years who had previously been treated with alendronate were randomized to 5 more years of alendronate or to placebo. A prior report of this study found that although hip BMD decreased in the placebo group, rates of fracture were similar between the group randomized to placebo and the group that continued on bisphosphonate therapy (Black, 2006). It should be noted that alendronate has a half-life in humans that is estimated to exceed 10 years (Gourlay, 2014).  During the 5 years of placebo, 94 of 437 women (22%) experienced 1 or more symptomatic fractures; most of these (87%) occurred after 1 year. Post-hoc analysis found that older age and lower hip (but not spine) DXA at time of discontinuation were significantly related to increased fracture risk; however, changes in BMD between the beginning of discontinuation to years 1 and 3 were not.
 
There is a lack of evidence of a clinical benefit of serial measurement of BMD for patients who have discontinued pharmacologic osteoporosis treatment.
 
National Osteoporosis Foundation
The National Osteoporosis Foundation (NOF) updated its practice guidelines in 2014 (NOF, 2014).  NOF guidelines recommend that all postmenopausal women and men age 50 and older should be evaluated clinically for osteoporosis risk to determine the need for BMD testing.
Indications for BMD testing are:
  • Women age 65 and older and men age 70 and older, regardless of clinical risk factors
  • Younger postmenopausal women and men age 50-69 with clinical risk factors for fracture
  • Adults who have a fracture after age 50
  • Adults with a condition or taking a medication associated with low bone mass or bone loss
 
NOF states that measurements for monitoring patients should be performed in accordance with medical necessity, expected response and in consideration of local regulatory requirements. NOF recommends that repeat BMD assessments generally agree with Medicare guidelines of every two years, but recognizes that testing more frequently may be warranted in certain clinical situations.
 
NOF also indicates that “Central DXA assessment of the hip or lumbar spine is the “gold standard” for serial assessment of BMD. Biological changes in bone density are small compared to the inherent error in the test itself, and interpretation of serial bone density studies depends on appreciation of the smallest change in BMD that is beyond the range of error of the test. This least significant change (LSC) varies with the specific instrument used, patient population being assessed, measurement site, technologist’s skill with patient positioning and test analysis, and the confidence intervals used. Changes in the BMD of less than 3-6 percent at the hip and 2-4 percent at the spine from test to test may be due to the precision error of the testing itself.”
 
American College of Radiology
Practice guidelines from the American College of Radiology, last amended in 2014 (ACR, 2014) state that BMD measurement is usually appropriate in the following patient populations indicated whenever a clinical decision is likely to be directly influenced by the result of the test. Indications for DXA include but are not to the following patient populations:
  • All women age 65 years and older and men age 70 years and older (asymptomatic screening).
      • Women younger than age 65 years who have additional risk for osteoporosis, based on medical history and other findings. Additional risk factors for osteoporosis include:
a. Estrogen deficiency
b. A history of maternal hip fracture that occurred after the age of 50 years.
c. Low body mass (less than 127 lbs or 57.6 kg).
d. History of amenorrhea (more than 1 year before age 42 years).
      • Women younger than age 65 years or men younger than age 70 years who have additional risk factors, including:
a. Current use of cigarettes
b. Loss of height, thoracic kyphosis.
  • Individuals of any age with bone mass osteopenia, or fragility fractures on imaging studies such as radiographs, computed tomograghy (CT, of magnetic resonance imaging [MRI])
  • Individuals age 50 years and older who develop a wrist, hip, spine, or proximal humerus fracture with minimal or no trauma, excluding pathologic fractures.
  • Individuals of any age who develop 1 or more insufficiency fractures.
  • Individuals receiving (or expected to receive) glucocorticoid therapy for more than 3 months.
  • Individuals beginning or receiving long-term therapy with medications known to adversely affect BMD (e.g., anticonvulsant drugs, androgen deprivation therapy, aromatase inhibitor therapy, or chronic heparin.
  • Individuals with an endocrine disorder known to adversely affect BMD (e.g., hyperparathyroidism, hyperthyroidism, or Cushing’s syndrome).
  • Hypogonadal men older than 18 years and men with surgically or chemotherapeutically induced castration.
  • Women younger than age 65 years who have additional risk for osteoporosis, based on Individuals with medical conditions that could alter BMD, such as:
a. Chronic renal failure.
b. Rheumatoid arthritis and other inflammatory arthritis..
c. Eating disorders, including anorexia nervosa and bulimia.
d. Organ transplantation.
e. Prolonged immobilization.
f. Conditions associated with secondary osteoporosis, such as gastrointestinal malabsorption or malnutrition, sprue, osteomalacia, vitamin D deficiency, acromegaly, chronic alcoholism chronic alcoholism or established cirrhosis, and multiple myeloma
g. Individuals who have had gastric bypass for obesity. The accuracy of DXA in these patients might be affected by obesity.
  • Individuals being considered for pharmacologic therapy for osteoporosis.
  • Individuals being monitored to:
a. Assess the effectiveness of osteoporosis drug therapy.
b. Follow-up medical conditions associated with abnormal BMD.
 
International Society for Clinical Densitometry
The 2013 update of the International Society for Clinical Densitometry guidelines recommend bone density testing in the following patients (ISCD, 2013):
  • Women age 65 and older;
  • Postmenopausal women under age 65 with risk factors for fracture such as;
      • Low body weight
      • Prior fracture
      • High risk medication use
      • Disease or condition associated with bone loss.
  • Women during the menopausal transition with clinical risk factors for fracture, such as low bone weight, prior fracture or high-risk medication use;
  • Men age 70 and older;
  • Men under age 70 if they have a risk factors for low bone mass such as;
      • Low body weight
      • Prior fracture
      • High risk medication use
      • Disease or condition associated with bone loss.
  • Adults with a fragility fracture
  • Adults with a disease or condition associated with low bone mass or bone loss
  • Anyone being considered for pharmacologic therapy;
  • Anyone being treated, to monitor treatment effect.
  • Anyone not receiving therapy in whom evidence of bone loss would lead to treatment
 
In 2010 the American Association of Clinical Endocrinologists issued guidelines for the diagnosis and treatment of postmenopausal osteoporosis.25 The guidelines list the potential uses for BMD measurements in postmenopausal women as:
  • Screening for osteoporosis
  • Establishing the severity of osteoporosis or bone loss
  • Determining fracture risk
  • Identifying candidates for pharmacologic intervention
  • Assessing changes in bone mass over time
  • Enhancing acceptance of and perhaps adherence with treatment
  • Assessing skeletal consequences of diseases, conditions, or medications known to cause bone loss
 
The North American Menopause Society issued a 2010 position statement 26 which states that fracture is the most significant risk of low bone density. The statement also concludes that Bone Mineral Density (BMD) is an important determinant of fracture risk, especially in women 65 years and older.
  
2017 Update
A literature search conducted through February 2017 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Crandall and colleagues reported results from 11,392 participants in the Women’s Health Initiative (WHI) BMD Cohort, a prospective observational study of postmenopausal women with a mean follow-up of 8.5 years (Crandall, 2015). Each standard deviation decline in lower BMD measured with central DXA was associated with higher wrist fracture risk, the adjusted hazard ratio (HR) being 1.7 (95% CI, 1.4 to 1.9) for femoral neck BMD and 1.5 (95% CI, 1.3 to 1.6) for lumbar spine BMD.
 
Cauley and colleagues reported risk factors for hip fractures in 5994 men with a mean of 8.6 years of follow-up from the Osteoporotic Fractures in Men Study (Cauley, 2016). Femoral neck BMD was measured using DXA. The incidence rate of hip fracture 33.4 per 1000 person-years in men with BMD T scores less than -2.5 who also had 4 or more risk factors, 14.5 per 1000 person-years in men age 80 years and older with 3 or more major comorbidities, and 0.88 per 1000 person-years in men age less than 70 years with zero comorbidities. Low BMD by World Health Organization classification (T score < -2.5 ) was highly associated with hip fracture (hazard ratio [HR], 3.3; 95% CI, 2.7 to 3.9) in a competing risk model after adjusting for several other fracture risk factors (eg, age, previous fracture).
 
Leslie and colleagues reported on repeat BMD measurements in clinical practice for fracture risk assessment from a large clinical BMD database for Manitoba, Canada, of women and men ages 50 years and older from 1990 to 2009 (Leslie, 2016). BMD was measured in the hip, lumbar spine, and femoral neck using DXA. A total of 50,215 participants had 1 BMD measurement, 14,619 had a second measurement, 4722 had a third measurement, and 1500 had a fourth measurement. The mean time between measurements was 4.2 years. Total hip BMD was predictive of major osteoporotic fracture at each time point. The association between BMD and major osteoporotic fracture was similar for the first and second BMD measurements: adjusted hazard ratios per standard deviation were 1.5 (95% CI, 1.3 to 1.6) and 1.6 (95% CI, 1.5 to 1.8), respectively. The hazard ratio for the second measurement was similar when stratified by preceding change in BMD or osteoporosis therapy.
  

CPT/HCPCS:
76977Ultrasound bone density measurement and interpretation, peripheral site(s), any method
77078Computed tomography, bone mineral density study, 1 or more sites, axial skeleton (eg, hips, pelvis, spine)
77080Dual-energy X-ray absorptiometry (DXA), bone density study, 1 or more sites; axial skeleton (eg, hips, pelvis, spine)
77081Dual-energy X-ray absorptiometry (DXA), bone density study, 1 or more sites; appendicular skeleton (peripheral) (eg, radius, wrist, heel)
78350Bone density (bone mineral content) study, 1 or more sites; single photon absorptiometry
78351Bone density (bone mineral content) study, 1 or more sites; dual photon absorptiometry, 1 or more sites

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